KM-4 Metal-Backed Acetabular Cup

No FDA recalls on record, checked 22 Oct 2026.

Full name

Km-4(Tm) Metal-Backed Acetabular Cup

510(k) Number

K870867 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Dosimetric Release of Gamma Radiation

  Class II

  FDA 510(k) K832211 Active Cleared 29 Sep 1983

• Austin Moore Hip Prosthesis

  Not classified

  FDA 510(k) K863896 Active Cleared 19 Nov 1986

• Dimension Total Hip Prosthesis

  Class II

  FDA 510(k) K853333 Active Cleared 3 Sep 1985

• Compression System

  Class II

  FDA 510(k) K831076 Active Cleared 28 Apr 1983

• Wire & Steinman Pins

  Class II

  FDA 510(k) K831005 Active Cleared 18 May 1983

• Kirschner(R) Modular II-C(Tm) Total Shoulder System

  Class II

  FDA 510(k) K940537 Active Cleared 29 Aug 1995

See all devices from Kirschner Medical Corp. →

• Is the KM-4 Metal-Backed Acetabular Cup designed for single-use or can it be reused in multiple procedures?

  The KM-4 Metal-Backed Acetabular Cup is explicitly described as a reusable medical device. It is intended for use in multiple orthopedic surgical procedures, provided it is handled and maintained according to sterile surgical protocols. Reuse is permitted under its FDA 510(k) clearance, which classifies it as a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabulum).

• What types of inserts are compatible with the KM-4 Metal-Backed Acetabular Cup, and how does this affect joint articulation?

  The KM-4 is designed to accommodate either polyethylene or ceramic inserts, which articulate with the femoral component to restore joint function. The choice of insert material influences durability, wear resistance, and smooth articulation, helping to alleviate pain and improve mobility in total hip arthroplasty.

• Are there multiple sizes or models available for the KM-4, and how would a clinician determine the correct fit for a patient?

  While the provided data lists multiple FEI numbers (e.g., 3020282716, 1047843), these are administrative identifiers for regulatory tracking, not direct size or model specifications. Clinicians must rely on manufacturer-provided sizing guides or intraoperative measurements to select the appropriate KM-4 acetabular cup size for a patient’s anatomy, ensuring proper fit and stability during total hip replacement.

• Can the KM-4 Metal-Backed Acetabular Cup be used in patients who require MRI imaging post-surgery?

  No, the KM-4 is not indicated for MRI use. The device must be handled and stored according to sterile surgical protocols, and patients should be informed of MRI restrictions due to the metallic components, which could interfere with imaging or pose safety risks.

• What storage and handling requirements apply to the KM-4 to maintain sterility and functionality?

  Since the KM-4 is reusable, it must be sterilized and maintained per sterile surgical protocols before and after each use. The manufacturer’s instructions (not detailed here) should specify cleaning, sterilization methods (e.g., autoclave), and storage conditions to prevent contamination or damage. Proper handling ensures longevity and compliance with orthopedic surgical standards.